The following data is part of a premarket notification filed by Ilooda Co., Ltd with the FDA for Mtx-c1.
| Device ID | K212561 |
| 510k Number | K212561 |
| Device Name: | MTX-C1 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ILOODA Co., Ltd 120, Jangan-ro 458 Beon-gil, Jangan-Gu Suwon-si, KR 16200 |
| Contact | Yun-Jung Ha |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St. Ste 610 Houston, TX 77054 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-13 |
| Decision Date | 2022-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023201895 | K212561 | 000 |